RHINATHIOL PROMETHAZINE Syrup

Indications:

This medicine is used to relieve dry and irritating cough, especially when occurring in the evening or at night.

Rhinathiol Promethazine is for adults and children aged over 2 years only.

Dosage:

This medicine is for adults and children aged over 2 years only.

Always follow the dose recommended in this leaflet. Check with your doctor or pharmacist if you are not sure.

This medicine has been dispensed to you personally, in a specific situation:

• It may be unsuitable in other situations.

• Do not pass it on to others.

Adults:

The usual dose is 3 or 4 tablespoons of syrup per day (one tablespoon is equivalent to 15 ml of syrup).

Children aged 2 to 15 years:

Use the 5 ml measuring spoon provided with this syrup. Wash the measuring spoon after each use.

The daily dose depends on your child’s age:

• Children aged 24 to 30 months: three or four 5 ml measuring spoons per days.

• Children aged 30 months to 12 years: four to six 5 ml measuring spoons per day.

• Children aged 12 to 15 years: six to nine 5 ml measuring spoons per day.

Method of administration

This medicine should be taken by mouth.

The measuring spoon provided with the bottle of syrup is to be used for children only.

During of treatment

Treatment should be short-term (a few days) and should only be taken when coughing occurs.

If you take more Rhinathiol Promethazine than you should:

Contact your doctor or the emergency services immediately. Rhinathiol Promethazine overdose may cause seizures (especially in children), impaired alertness and coma.

If you stop taking Rhinathiol Promethazine:

Not applicable.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Do not take Rhinathiol Promethazine:

• If you are allergic to any of the active substances (Promethazine or carbocisteine) or any of the other ingredients of Rhinathiol Promethazine.

• If you are allergic to a medicine belonging to the same group as Rhinathiol promethazine (antihistamines) used to treat allergies.

• If you are at risk of narrow-angle glaucoma (increased pressure inside the eye with a possible impact on eyesight).

• If you experience difficulty passing urine (due to prostate or other disorders).

• If you are taking medicine containing cabergoline or quinagolide (used to reduce excessive prolactin production).

• In children aged under 2 years.

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

• Worsening of bronchial congestion, especially in infants and certain patients unable to cough up sputum effectively.

• Stomach pain, nausea, vomiting, diarrhea. If these occur, the dose should be reduced.

• Bleeding in the stomach or intestine. Treatment should be stopped.

• Allergic skin reactions such as itching, skin rash, hives and swelling of the face.

• Fixed drug eruption (brown marks on the skin).

• Appearance of spots, sometimes with blisters, on the skin that can also affect the mouth (erythema multiforme), appearance of blisters with detachment of the skin that can spread over the whole body and may be life-threatening (Stevens-Johnson syndrome).

Stop the treatment and contact your doctor immediately:

• If you have signs of allergy to the medicine, such as:

o Redness, itching (pruritus), eczema, purple marks on the skin (purpura),

o Hives,

o Edema, sudden swelling of the face and/or neck that can lead to difficulty breathing and be life-threatening (angioedema),

o Asthma attack,

o Sudden malaise with a significant decrease in blood pressure (anaphylactic shock).

• If you have an excessive skin reaction after exposure to sun or UV radiation.

• If you have symptoms possibly caused by a decrease in white blood cell, platelet or red blood cell counts. These symptoms can be recognized by:

o Fever, sometimes with infection (caused by a major drop in white blood cell count).

o Nosebleed or bleeding gums (caused by an abnormal reduction in platelet count).

The following effects can occur more frequently:

• Drowsiness, reduced alertness, particularly at the start of treatment,

• Memory or concentration disorders, dizziness (especially in patient aged over 65 years),

• Difficult in coordinating movements, tremor,

• Confusion, hallucinations,

• Dry mouth, visual disturbances, difficulty passing urine (urinary retention), constipation, heart palpitations, major drop in blood pressure upon standing up, which sometimes causes dizziness and/or malaise (postural hypotension).

You should avoid drinking alcoholic beverages and taking medicines containing alcohol during treatment.

Pregnancy:

• At the end of pregnancy, taking excessive amounts of this medicine can have harmful effects on the newborn baby.

• If you discover that you are pregnant during treatment, talk to your doctor as soon as possible. Only your doctor will be able to adapt your treatment to your condition.

Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding:

As a precautionary measure, breast-feeding is not recommended for new-borns.

Ask your doctor or pharmacist for advice before taking any medicine.

Infants: if your infant has a cough, you should see a doctor.

• This medicine must not be used in infants aged under 2 years because of the risk of serious respiratory disorders related to the promethazine and carbocisteine content of the syrup.

• If cough persists despite using Rhinathiol Promethazine, do not increase the doses. Contact your doctor. Cough is a symptom which can have the doses. Contact your doctor. Cough is a symptom which can have different causes: Respiratory infection, bronchitis, influenza, allergy, asthma, whooping cough, irritation, etc.

Furthermore, tobacco use causes coughing to worsen or persist.

• There are 2 types of cough: dry cough and productive cough. You should not use this medicine to treat a productive cough. Productive cough is a natural defense mechanism which is necessary in order to expel bronchial secretions (mucus).

• If a productive cough develops, with congestion, sputum or fever, ask your doctor for advice.

• Do not attempt to treat a productive cough by using a syrup for productive cough at the same time as this medicine.

• You should avoid exposure to sun and ultraviolet radiation (UVA) during treatment.

Talk to your doctor before taking Rhinathiol Promethazine:

• If you have chronic bronchial or pulmonary disease involving coughing and production of sputum.

• If you have chronic liver disease (severe liver failure) or kidney disease (severe kidney failure). Your doctor should adapt the dose to your condition.

• If you have cardiovascular disease.

• If you have epilepsy.

• If you are aged over 65 years (particularly if you experience chronic constipation, difficulty passing urine due to an enlarged prostate hypotension, dizziness or drowsiness).

• If your child has asthma or gastroesophageal reflux.

• This medicine may cause drowsiness and should be used with caution.

• If you have a gastroduodenal ulcer (affecting the stomach or intestine).

• During co-administration with medicine is liable to cause bleeding in the stomach or intestine.

Treatment should be stopped if bleeding in the stomach or intestine occurs.

Pharmacotherapeutic group: Rhinathiol promethazine is a cough suppressant belonging to a group of medicines called antihistamines. It blocks the effects of histamine, especially on the bronchi.

This medicine also contains carbocisteine.

This medicine is used to relieve dry and irritaitng cough, especially when occurring in the evening or at night.

Rhinathiol promethazine is for adults and children aged over 2 years only.