Sopharma – Rhinolex Ointment (18 g)

Do not use Rhinolex:

• if you are allergic (hypersensitive) to the active substances or to any of the other ingredients of Rhinolex;
• if you suffer from atherosclerosis;
• if you have severe organic heart disease;
• for children under 6 years.

Take special care with Rhinolex:

• if you have cardiovascular diseases such as high blood pressure, heart failure, ischemic heart disease (insufficient blood supply to the heart muscle), advanced atherosclerosis, narrow-angle glaucoma (increased intraocular pressure), diabetes, difficulty urinating;
• used with caution in patients with congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase (required for the breakdown of sulfathiazole);
• if you are allergic to thiazide diuretics (furosemide), carbonic anhydrase inhibitors (used to treat epilepsy, diuretics), sulphonylureas (antidiabetics), guanethidine, sulphonamides;
• The medicinal product must not be used by athletes before competitions, as it contains ephedrine, which may test positive for doping.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Due to topical application of Rhinolex, no significant drug interactions were observed.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. The use of the product is not recommended during pregnancy and lactation due to the content of ephedrine and sulfathiazole. It is used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Driving and using machines:

No data are available on the ability to drive and use machines.

Side effects

Like all medicines, Rhinolex can cause side effects, although not everybody gets them.

About 15-30 minutes after administration of larger amounts of the product, transient drug reactions may occur, manifested by palpitations, a slight increase in blood pressure, tremor (tremor) of the limbs, anxiety, insomnia in children.

Sometimes causes allergies (hypersensitivity) at the site of application, manifested in irritation, burning and itching. General reactions such as increased sweating may also occur.

With long-term use of Rhinolex may develop a tolerance (reduction of the therapeutic effect).

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.

Storage of Rhinolex:

Store in the original package, at a temperature below 25 ° С.

Keep out of reach of children.

Shelf life after opening the tube – 1 month.

Do not use Rhinolex after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

RHINOLEX ointment 18 g SOPHARMA

PACKAGE LEAFLET: USER INFORMATION
RHINOLEX 30 mg/g + 50 mg/g nose ointment
RHINOLEX 30 mg/g + 50 mg/g nasal ointment

ephedrine hydrochloride/sulfathiazole

Read all of this leaflet carefully as it contains important information for you.

This medicine can only be obtained without a doctor’s prescription. However, in order to get the best treatment results, you should carefully follow the instructions for use of the medicinal product.
Keep this leaflet. You may have to read it again.
If you need further information or advice, ask your pharmacist.
You should seek medical attention if your symptoms worsen or do not improve after the time limit set by your doctor.
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.

In this leaflet:

1. What Rhinolex is and what it is used for
2. Before using Rhinolex
3. How to use Rhinolex
4. Possible side effects
5. How to store Rhinolex
6. Further information

1. WHAT RHINOLEX IS AND WHAT IT IS USED FOR

Rhinolex is a combined medicinal product in the form of nasal ointment. It is used in acute rhinitis (runny nose) or in exacerbation of chronic rhinitis and sinusitis (chronic inflammation of the nasal mucosa and paranasal cavities).

2. BEFORE USING RHINOLEX
Do not administer Rhinolex:

• if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Rhinolex;
• if you suffer from atherosclerosis;
• if you have severe organic heart disease;
• in children under 6 years.

Pay special attention to the use of Rhinolex

• if you have cardiovascular diseases such as high blood pressure, heart failure, ischemic heart disease (insufficient blood supply to the heart muscle), advanced atherosclerosis, narrow-angle glaucoma (increased intraocular pressure), diabetes, prostate enlargement with difficulty urinating;
• it is used with caution in patients with congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase (necessary for the breakdown of sulfathiazole);
• if you have an allergy to thiazide diuretics (furosemide), carbonic anhyirritation inhibitors (for the treatment of epilepsy, diuretics), sulphonylureas (antidiabetics), guanethidine, sulphonamides;
• The medicinal product should not be used by athletes before participating in competitions as it contains ephedrine, which may test positive for doping.

Use of other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Due to topical administration of Rhinolex, no significant drug interactions were observed.

Use of Rhinolex with food and drink

There are no contraindications.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.
The use of the product is not recommended during pregnancy and lactation due to the content of ephedrine and sulfathiazole. It is used only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Driving and using machines

There is no evidence of interference with the ability to drive and use machines.

3. HOW TO APPLY RHINOLEX

Always use Rhinolex exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is administered only nasally. After preliminary cleaning of the nose, smear the nostrils with a small amount (about 1 cm) of the ointment.
Adults: 3-4 times a day for 5 days.
Children over 6 years: 2-3 times a day for 3 days.

If you have applied more Rhinolex

If you have applied more than the ointment, please ask your doctor or pharmacist for advice.

If you forget to use Rhinolex

Do not apply double the amount of ointment to compensate for what was missed. Administer the next dose at the time specified by the doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Rhinolex can cause side effects, although not everybody gets them.
About 15-30 minutes after administration of larger amounts of the product, rapid transient drug reactions may be observed, such as palpitations, slight increases in blood pressure, tremor (trembling) of the limbs, restlessness, insomnia in children.
Sometimes it causes allergies (hypersensitivity) at the site of application, expressed in irritation, burning and itching. Common reactions such as increased sweating may also be observed.
With prolonged use of Rhinolex, the development of tolerance (lowering the healing effect) may be observed.

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.

5. HOW TO STORE RHINOLEX

Store in the original package at a temperature below 25 °C. Keep out of the reach of children.

Shelf life after opening the tube – 1 month.
Do not use Rhinolex after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

6. ADDITIONAL INFORMATION

What Rhinolex contains

The active substances are ephedrine hydrochloride 30 mg; sulfathiazole 50 mg in 1 g. Ointment.
The other ingredients are: cineole (eucalyptol), nial (gomenol) oil, sodium hydrogen carbonate; paraffin, liquid; Lanolin; paraffin, white soft.

What Rhinolex looks like and contents of the pack

Ointment with yellow color and specific smell of eucalyptol and gomenol.
18 s ointment in an aluminum tube with a plastic cap, one tube in a cardboard box, along with a leaflet.

Marketing Authorisation Holder and manufacturer:

SOPHARMA AD, Bulgaria.