Sodium Oxybate 500mg/ml oral solution

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT THIS MEDICINE IS

The name of this medicine is TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment. The key ingredient in this medicine is called Tetracycline Hydrochloride. This belongs to a group of medicines called tetracycline antibiotics.

2. WHAT THIS MEDICINE IS USED FOR

TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment can be used:

Tetracycline hydrochloride is indicated in the treatment and prophylaxis of certain superficial eye infections such as conjunctivitis and bacterial infections in seasonal epidemics.

Tetracycline hydrochloride is also indicated to treat trachoma and ophthalmia neonatorum, for prophylaxis and treatment of gonococcal or chlamydial conjunctivitis in the newborn and in non- gonococcal conjunctivitis.

3. BEFORE YOU TAKE THIS MEDICINE

• Do not take this medicine and tell your doctor if:
• You are allergic to Tetracycline hydrochloride or any of the other ingredients in your medicine. Eye-tuberculosis Mycosis

Take special care with Tetracycline and tell your doctor if:

• If you experience itching and swelling of the eyelids, reddening of the eye, swelling of the face or throat, skin rash or any other symptom of an allergic reaction, stop using Tetracycline and contact your attending physician.
• You may become more sensitive to sunlight while using Tetracycline. Avoid exposure to intensive sunlight during this period.

Taking other medicines

Tell your doctor if you are taking/using, have recently taken/used or might take/use any other medicines. Tetracycline may affect the activity of other topical antibiotics (penicillin, cephalosporins, aminoglycosides), for which, they should not be applied simultaneously. The simultaneous administration of Tetracycline with corticosteroids for ocular use (dexamethasone, prednisolone or hydrocortisone) is not recommended, since some unfavorable symptoms may be masked. If you are not sure, talk to your doctor or pharmacist before taking tetracycline hydrochloride.

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 using this medicine. If you are pregnant, making attempts to get pregnant or breast-feeding at present, Tetracycline should be administered with caution and by your attending physician prescription only, since it may affect the skeletal development, bone growth and teeth of the baby.

Driving and using machines

As with all products for ocular use, transient blurring of vision or other disturbances may affect the ability to drive and use machines. You should wait until your vision clears, before you start operating machines or driving.

4. HOW TO TAKE THIS MEDICINE

Instructions for proper instillation of the eye ointment:

1. Hold the tube in hand several minutes to warm before use.

 2. Wash your hands.

3. Lie down or tilt the head backward and look at the ceiling.

4. Pull the lower eyelid away from the eye to form a pouch. 

5. Squeeze a thin strip of ointment into the pouch. 

6. A 1-cm strip of the ointment should be enough unless otherwise directed by your doctor. 

7. Gently close your eyes for 1 or 2 minutes and roll the eyeball in all directions while the eye is closed, to allow the medicine to come into contact with the infection. 

8. Temporary blurring may occur.

Do not touch the tip of the tube or cap to the eye, fingers or any surface. Using a clean tissue, remove the excessive amount of the ointment from the eyelid or eyelashes. Using another clean tissue, wipe the tip of the tube and close it tightly with the cap. Treatment should be continued according to the instructions of a physician. If you think that your tube is contaminated, contact your doctor before continuing the application of this eye ointment.

How much to apply:

Treatment of superficial bacterial infections of the eye: Administer a 1-cm strip of the ointment every 4-6 hours into the lower conjunctival sac. Both eyes should always be treated. Treatment should be continued during the night. Do not stop treatment until well after clinical cure.

Treatment of trachoma: Administer a 1-cm strip of the ointment every 8 hours (three times daily) into the lower conjunctival sac. Both eyes should always be treated. Treatment should be continued for 2-3 weeks. Thereafter, for the next 6 months, TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment should be applied each month twice daily for 5 consecutive days. 

In areas with high trachoma prevalence: Apply TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment twice daily for 10 consecutive days. Repeat every 6 months.

Prophylaxis of neonatal chlamydial or gonococcal conjunctivitis: Administer a small amount of the ointment once into the lower conjunctival sac of both eyes as soon after delivery as feasible. If you forget to use TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment Apply the dose as soon as you remember. If it is almost the time for your next dose, continue according to your usual regimen. Do not apply a double dose to make up for a forgotten application. 

5. POSSIBLE SIDE EFFECTS

Like all medicines, Tetracycline can cause side effects, although not everybody gets them. There are reports of side effects, possibly related with the application of tetracycline for ocular use, but these are mild and rapidly alleviating after treatment discontinuation.

• Eye disorders: Blurred vision, sensation of burning, stinging, itching in the eye or eyelid, reddening of the conjunctiva, swelling of the eyelid, lacrimation (excessive tear discharge) pain, mydriasis (dilation of pupils), glaucoma.
• Immune system disorders: Local allergic reactions - inflammation and irritation of the skin, rash, itching, photodermatitis (increased sensitivity to sunlight and UV rays).
• General allergic reactions - rash, itching/swelling (of the face, tongue, throat), vertigo, shortness of breath. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

6. HOW TO STORE THIS MEDICINE

Keep out of the reach and sight of children. TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment should be stored protected from moisture, light, freezing and excessive heat at a temperature not exceeding 25°C. Do not use TETRACYCLINE HYDROCHLORIDE 1% ophthalmic ointment after the expiry date which is stated on the box and tube. The expiry date refers to the last day of that month. Dispose of the tube in 28 days after opening, to avoid eventual infections and contaminations. 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. 

7. FURTHER INFORMATION

What TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT 1% contains: The active ingredient is Tetracycline Hydrochloride. Each 5 g of ointment contains 50 mg of Tetracycline Hydrochloride. 

The other ingredients are: Hard Paraffin, Liquid Paraffin, White Soft Paraffin.

What TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT 1% look like and contents of the pack

TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT 1% is a yellow smooth ointment. It is supplied in collapsible aluminum tube volume 5g.

Marketing authorization holder: TROGE MEDICAL GMBH, Milch Strasse 19, Hamburg GERMANY.

Phone: +49 (0) 40 44 18 44-0, E-mail: info@trogemedical.de.