1% eye drops, atropine sulphate solution

1. What Isopto-Atropine is and what it is used for

Isopto-Atropine is a painkiller and pupil dilator. It is used in certain types of eye infections and to improve vision in some cases.

Isopto-Atropine eye drops can be used for treatment in children from 6 years of age and in adults.

Atropine sulphate contained in Isopto-Atropine may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you use Isopto-Atropine

Do not use Isopto-Atropine

  • if you are allergic to atropine sulphate or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to a group of medicines called belladonna alkaloids (atropine belongs to this group)
  • if you have or think you may have narrow-angle glaucoma .

Warnings and cautions

Talk to your doctor or pharmacist before using Isopto-Atropine.

Talk to your doctor as the use of Isopto-Atropine may cause:

  • increased pressure in the eye, especially if you have a shallow anterior chamber of the eye or a narrow anterior chamber angle . You should have your eye pressure checked regularly and even before starting treatment.
  • behavioral changes, especially in the elderly, but reactions can occur at any age.
  • photosensitivity. Protect your eyes in bright light.

If you have a fever or are in a hot climate, talk to your doctor before using Isopto-Atropine.

Children

  • If Isopto-Atropine 1% is given to children 6 years of age and older, consult your doctor. Serious side effects may occur with the use of this medicine in children, especially children with low weight, or children with Down syndrome, spastic paralysis, epilepsy or brain damage. See also “How to use Isopto-Atropine”.
  • children must be kept under close supervision for at least 30 minutes after the medicine has been given.
  • if Isopto-Atropine misses the eye, wash it off immediately.

Other medicines and Isopto-Atropine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking:

  • antihistamines (medicines for allergies )
  • antidepressants

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Isopto-Atropine should not be used during pregnancy unless clearly necessary.

Isopto-Atropine should not be used during breastfeeding.

Driving and using machines

This type of medicine can cause drowsiness, blurred vision, and photosensitivity. If you get any of these, do not drive or use any tools or machines.

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 . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Isopto-Atropine contains benzalkonium chloride and boric acid

This medicine contains 0.0035 mg benzalkonium chloride per drop equivalent to 0.1 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.

Do not use the medicine in children younger than 2 years as it contains boron and may cause impaired fertility in the future.

3. How to use Isopto-Atropine

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults, including the elderly

1-2 drops 1-3 times daily.

Older

Always use the lowest possible dose needed to give the desired effect.

Children (6 years and older)

1 drop 1-2 times daily in the eye.

Always use the lowest possible dose needed to give the desired effect.

See also the sections “Warnings and Cautions; Children ”,“ If you have used too much Isopto-Atropine ”and“ Possible side effects ”.

Use only Isopto-Atropine to drip into the eye (s).

How to use Isopto-Atropine correctly:

If the safety collar is loose after the cover has been removed, it must be removed before using the product.

User instructions
  1. Bring out the bottle of Isopto-Atropine.
  2. Wash your hands and sit in front of a mirror.
  3. Unscrew the cap on the bottle.
  4. Hold the bottle facing down between your thumb and forefinger (Fig. 1).
  5. Tilt your head back. Pull down the lower eyelid with a clean finger, until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should be placed.
  6. Move the bottle tip close to the eye. Use a mirror if it helps.
  7. Avoid touching the eye or eyelid, surrounding areas or other surfaces with the drip tip. It may contaminate the eye drops in the bottle.
  8. Do not squeeze the bottle. It is designed so that a light pressure on the bottom is all that is needed (Fig. 2).
  9. Gently press on the bottom of the bottle to release one drop of Isopto-Atropine at a time (Figure 3).
  10. After using Isopto-Atropine, close the eyelid and gently press with a finger in the corner of the eye at the nose for 2 minutes (Fig. 4). It helps prevent Isopto-Atropine from entering the rest of the body.
  11. If you are using Isopto-Atropine in both eyes, repeat steps 5 through 10 for your other eye.
  12. Tighten the bottle cap firmly immediately after use.

If a drop misses the eye, wipe it off immediately and try again.

If you are taking other medicines in the form of eye drops or eye ointments, wait at least 5 minutes between each use of the medicine. Eye ointments should be used last.

If you use more Isopto-Atropine than you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital or the Poison Information Center for risk assessment and advice.

If you have used too much Isopto-Atropine, rinse everything out with warm water. Do not drip in more drops until it is time for the next scheduled dose .

Symptoms of overdose may include: redness and dry skin (children may get a rash), blurred vision, rapid and irregular heartbeat , fever, bloated abdomen in infants, seizures, hallucinations or loss of coordination.

If you forget to use Isopto-Atropine

Continue with the next dose as planned. However, if it is almost time for your next dose , skip the missed dose and return to your regular dosing schedule.

Do not take a double dose to make up for a forgotten dose .

If you stop using Isopto-Atropine

Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using this medicine too soon, the symptoms may return.

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.

You may get the following reactions in your eyes:

Common (affects 1 to 10 users in 100): photosensitivity, eye pain and visual impairment.

Rare (affects 1 to 10 users in 10,000): narrow-angle glaucoma .

No known frequency (can not be calculated from the available data): swollen eyelids, blurred vision, increased pupil size (prolonged effect of the drug), conjunctivitis , red eyes, swollen eyes and watery eyes.

Reactions in other parts of the body:

Common (affects 1 to 10 users in 100): hallucinations, confusion, agitation, increased heart rate, constipation, flushing and fever.

No known frequency (can not be calculated from the available data) : allergy , confusion, dizziness, headache, lack of coordination, incoherent speech, restlessness, hyperactivity, seizures, inability to recognize other people, abnormal drowsiness, slower heart rate, decreased blood pressure , dilation of blood vessels, difficulty breathing, intestinal blockage, bloating, vomiting, decreased intestinal motility, skin inflammation or redness , rash, difficulty urinating, decreased secretion in the salivary and sweat glands, pharynx , bronchi and nasal passages.

Additional side effects are in children

Children, especially children with low weight and children with central nervous system disorders (eg epilepsy , brain damage or Down syndrome) are at increased risk of toxic effects. This can manifest as central nervous system disorders (similar to those listed above, eg, inconsistent speech, restlessness, hallucinations, hyperactivity, confusion) and can cause very high fever. Toxic effects can also appear as disorders of the heart, lungs and stomach.

5. How to store Isopto-Atropine

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

No special storage instructions.

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

The bottle is discarded 4 weeks after opening.

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 pack and other information

Content declaration

  • The active substance is atropine sulphate 10 mg.
  • The other ingredients are benzalkonium chloride ( preservative ), hypromellose, boric acid, sodium hydroxide and / or hydrochloric acid for pH adjustment and purified water.

What the medicine looks like and contents of the pack

Isopto-Atropine is a colorless solution supplied in a 5 ml plastic bottle (DROPTAINER) of LDPE with a screw cap.

Marketing Authorisation Holder

Alcon Nordic A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

Alcon Laboratories Belgium

Lichterveld 3

2870 Puurs-Sint-Amands

Belgium

Or

SA Alcon-Couvreur NV

Rijksweg 14

2870 Puurs

Belgium

Muhammad Nadeem

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